Needle and guidewire holder

ABSTRACT

Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician&#39;s hand to X-ray during the puncturing procedure.

FIELD OF THE INVENTION

The present invention generally relates to a device and a method forneedle puncturing of small blood vessels for small vessel angioplasty,such as below the knee (BTK) blood vessels and other small blood vessels(e.g., coronary, pediatric), which are partially or totally occluded.

BACKGROUND OF THE INVENTION

A chronic total occlusion (CTO) is an arterial vessel blockage thatprevents blood flow beyond the obstruction. CTO's typically occur incoronary, peripheral, pediatric, and either small arteries. In thecoronary and peripheral arteries, they result from the same underlyingcause—atherosclerosis.

Endovascular therapies tor arteries below the knee have emerged as apromising revascularization technique for patients with critical limbischemia (CLI). However, when employing standard angioplasty techniques,angioplasty of BTK arteries fails to achieve revascularization in up to20% of cases. The main cause for failure is the inability to penetratethe plaque's proximal cap with the guidewire.

A new technique of approaching the plaque from below—known as theretrograde approach—is often used to pass the guidewire through theplaque from the other direction. This approach has high success rates,but is technically challenging to perform and has its own complications,especially the danger of vessel perforation.

In order to use the retrograde technique, the clinician must puncturethe small target artery with a needle—usually smaller than a 21 gaugeneedle. The clinician relies on several angiographic images to aim theneedle into the artery, and verifies proper needle tip location byobserving blood flow exiting from the needle's proximal end.

Puncturing small arteries is not easy; it requires proper manipulationof the C-arm and a gentle needle stick to avoid arterial perforation.Once a guidewire is inserted (through a small sheath or directly(sheath-less) through the skin) within the needle into the artery, theneedle can be removed.

Currently, relative short standard needles are used to puncture smallblood vessels. Long needles that might potentially extend the user handfrom the puncturing site are not used for two reasons:

1) Long thin needles are too flexible, which prevents accurate andcontrolled positioning of the needle tip in the direction of the bloodvessel; and

2) Blood is expected to come out from the proximal end of the needle.This is fine for a short needle, but for a long needle the blood may notreach the proximal end due to low blood pressure in the treated vesseland high flow resistance of the long narrow needle lumen.

Another important disadvantage of the prior art, is that during thisneedle insertion the clinician's hand is exposed to direct X-rayradiation which may have deleterious long-term health effects.

SUMMARY OF THE INVENTION

The present invention is directed to a device and a method for needlepuncturing of blood vessels for vessel angioplasty. The invention seeksto provide a special needle holder that facilitates needle insertion,and increases the needle puncturing procedure accuracy, while preventinghand exposure to radiation.

In accordance with an embodiment of the invention, a standard needles isaffixed onto a special extended needle holder, e.g., by using a femaleto male standard luer connection. The needle holder reduces theclinician'hand exposure to x-rays during the needle insertion andprovides better control of the needle trajectory and puncture. Thedevice includes a vent for both blood passage to confirm needle tiplocation in the target artery and for guidewire passage. A standardguidewire may be inserted through the needle into the artery.Afterwards, the needle and needle holder are removed.

Optionally, a guidewire holding mechanism is provided that reducesprocedure time and minimizes blood spillage, by holding the distalportion of the guide wire inside the needle holder.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description taken in conjunction with thedrawings in which:

FIG. 1 is a simplified cross-sectional illustration of a needle holder,in accordance with an embodiment of the present invention.

FIG. 2 is a simplified cross-sectional illustration of a needle holderwith a guidewire holder, in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIG. 1, which illustrates a needle holder 10,constructed and operative in accordance with an embodiment of thepresent invention.

Needle holder 10 is an elongate stiff member 13 that includes a needleconnector 14, such as but not limited to, a male luer connector, at adistal end 15 thereof. Connector 14 connects to a needle 11, such as bymeans of connecting with a female luer connector affixed to the proximalend of the needle 11. Needle holder 10 may be supplied without theneedle 11 and the user connects the holder to the needle. Alternatively,needle holder 10 may be supplied with needle 11 already assembledtherewith. Without limitation, needle holder 10 preferably has a lengthof at least 12 cm, most preferably in the range of 20-25 cm; holder 10is preferably longer than the needle 11. The elongate stiff member 13may be a hollow tube with a lumen 16, which may be made, withoutlimitation, from a stiff, clear polymeric material, e.g., polycarbonate.Lumen 16 is big enough for easy blood flow therethrough, preferably, butnot necessarily, having a diameter of equal to or more than 1.0 mm.

The long and stiff holder 10 reduces the clinician's hand exposure tox-rays during insertion of needle 11, and provides better control of theneedle orientation, trajectory, and puncture.

Needle holder 10 includes a vent 12 at a proximal end thereof for bloodflow to verify that the needle tip is property located inside the bloodvessel. Vent 12 preferably, but not necessarily, has a standard femaleluer shape.

Reference is now made to FIG. 2, which illustrates a needle holder 10and guidewire holder 17, constructed and operative in accordance with anembodiment of the present invention.

Guidewire holder 17 may be used to hold the distal portion of aguidewire 25 inside the needle holder lumen before and during bloodvessel puncturing. The option to hold the guidewire distal sectioninside the needle holder lumen may be useful for the operator, becauseit eliminates the need to look for the guidewire at the operation table,while holding the needle and needle holder steady. It reduces the amountof blood coming out of the needle, and spillage near the patient, byshortening the time needed to insert the guidewire through the needle.

Guidewire holder 17 includes a guidewire locking element 18, which maybe made of a flexible material, such as but not limited to, silicone. Asliding knob 19 is arranged to slide over guidewire locking element 18,which forces element 18 through a small hole 41 in elongate stiff member13 into lumen 16, thereby pressing the distal end of guidewire 25against the inner wall of lumen 16 and holding guidewire 25 in place. Torelease guidewire 25, the user slides sliding knob 19 to releaseguidewire locking element 18 from lumen 16.

A vent hole 20 may be added to elongate stiff member 13 distal toguidewire holder 17 to allow free blood flow outwards from the needle,even if lumen 16 is blocked by guidewire holder closing element 18.

Guidewire locking element 18 and/or other locking elements can bealternatively assembled to vent 12.

In accordance with an embodiment of the present invention, the proceduresteps are:

a. Fix needle 11 into connector 14.

b. Optionally insert and lock the distal portion of guidewire 25 insideneedle holder lumen 16.

c. Using x-ray angiography, insert and adjust the needle and needle tipuntil entering the blood vessel.

d. Conform needle tip is inside the blood vessel by looking at bloodcoming up into lumen 16 of elongate stiff member 13.

e. Insert guidewire 25 through vent 12 (e.g., female luer) and lumen 16(if not inserted and locked before), through connector 14 and needle 11,and into the blood vessel.

f. Extract needle holder 10 together with needle 11 from the patient,and remove proximally from guidewire 25.

g. Continue the angioplasty procedure.

What is claimed is: 1-10. (canceled)
 11. A method comprising: (i)connecting a needle to a needle holder, the needle holder comprising: anelongate stiff member having a proximal end, a distal end, and alongitudinal axis; a connector coupled to the distal end of the elongatestiff member; a guidewire holder coupled to the elongate stiff memberproximally of the distal end, the guidewire holder comprising: (a) aflexible locking element located proximally of the distal end of theelongate stiff member; (b) a sliding knob arranged to slide over thelocking element in a direction parallel to the longitudinal axis andforce the flexible locking element in a radial direction; a lumentraversing the connector, the elongate stiff member, and the guidewireholder, wherein the lumen comprises an inner wall and an opening,wherein the opening is disposed proximally of the locking element; (ii)inserting a guidewire into the lumen; (iii) after (ii), sliding thesliding knob thereby causing the flexible locking element to directlycontact and hold the guidewire in position relative to the connector;(iv) after (iii), inserting the needle into a blood vessel; (v) after(iv), sliding the sliding knob thereby releasing the flexible lockingelement from holding the guidewire in the position relative to theconnector; and (vi) after (v), inserting the guidewire into the bloodvessel through the lumen and the needle.
 12. The method according toclaim 11, wherein inserting the needle into the blood vessel comprisesusing x-ray angiography.
 13. The method according to claim 11, furthercomprising confirming that the needle is positioned in the blood vesselby viewing blood in the elongate stiff member.
 14. The method accordingto claim 11, further comprising, after (vi), removing the needle holdertogether with the needle from the blood vessel.
 15. The method accordingto claim 14, further comprising removing the needle holder and theneedle proximally from the guidewire.
 16. The method according to claim15, further comprising conducting an angioplasty procedure afterremoving the needle holder and the needle proximally from the guidewire.17. The method according to claim 11, wherein (iii) sliding the slidingknob comprises sliding the sliding knob in a first direction, andwherein (v) sliding the sliding knob comprises sliding the sliding knobin a second direction.
 18. The method according to claim 11, whereininserting the needle into the blood vessel comprises inserting theneedle with a retrograde approach.
 19. The method according to claim 11,wherein the blood vessel is an artery.
 20. The method according to claim19, wherein inserting the needle into the artery comprises inserting theneedle with a retrograde approach.
 21. The method according to claim 20,further comprising, after (vi), removing the needle holder together withthe needle from the artery.
 22. The method according to claim 21,further comprising conducting an angioplasty procedure after removingthe needle holder together with the needle from the artery.
 23. Themethod according to claim 11, wherein the connector comprises a maleluer connector.
 24. The method according to claim 11, wherein theopening comprises a female luer connector.
 25. The method according toclaim 11, wherein the needle holder has a length of at least 12 cm. 26.The method according to claim 11, wherein the needle holder has a lengthof 20 cm to 25 cm.
 27. The method according to claim 11, furthercomprising a second opening in fluid communication with the lumen. 28.The method according to claim 27, wherein the second opening is locateddistal to the flexible locking element and proximal of the distal end ofthe elongate stiff member.
 29. The method according to claim 11, whereinthe elongate stiff member is constructed of a clear polymeric material.30. The method according to claim 11, wherein the flexible lockingelement is located within a hole within the elongate stiff member.